NIH/NCI 396 - Imaging for Cancer Immunotherapies

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Immunotherapies have emerged as one of the promising approaches for cancer treatment by exploiting patients’ own immune systems to specifically target tumor cells. However, it has been recognized that responses often occur in only a subset of patients in any given immunotherapy. This treatment is also associated with drug toxicity (e.g., cytokine storm), potential development of autoimmune diseases, in addition to the high cost. As this treatment modality continues to evolve, a significant clinical question that needs to be addressed is to determine which patients would benefit from immunotherapies. In addition, there is increasing need for newer methods to evaluate the efficacy and potential toxicities of the treatment, monitor cancer patients’ prognosis, and implement early interventional steps to minimize adverse effects upon completion of immunotherapies.

The purpose of this initiative is to provide much needed support for the development of cancer imaging technologies or approaches to identify patients who are likely to respond to cancer immunotherapies, evaluate the efficacy and potential toxicities of the treatment, and/or monitor cancer patients’ treatment prognosis. This solicitation is intended specifically to address cancer immunotherapies that depend upon eliciting an immune response. Projects that do not meet this requirement will not be funded. For example, a monoclonal antibody-based therapy that exerts a direct antitumoral effect either by neutralizing the antigen or by activating signaling pathways within the target tumor cells but does not elicit an immune response for its clinical application, is not considered an immunotherapy and would not be funded.

Project Goals

The goals of the solicitation are to develop a cancer imaging technology to identify patients who are likely to respond to cancer immunotherapies, evaluate the efficacy and potential toxicities of the treatment, and/or monitor cancer patients’ prognosis. The imaging modality could be one of the following, but is not limited to: ultrasound imaging, optical imaging, photoacoustic imaging, PET, SPECT, MRI or combination of multiple modalities. Molecular markers of interest could include but are not limited to: cell surface receptors, immune or associated non-immune cells, cellular infiltrates, enzymes, metabolites or metabolic states, DNAs, RNAs, or epigenetic modifications. The technology development should be platform driven. For example, the procedure for the cancer imaging that targets immunotherapy for breast cancer or its subtype should be easily applied for other cancer types/subtypes, such as colon cancer or prostate cancer. To apply for this topic, offerors need to outline and indicate the clinical question and unmet clinical need that their cancer imaging will address. Offerors are also required to use novel or validated imaging targets. This solicitation will not support efforts for imaging biomarker discovery.

The long-term goal of this solicitation is to enable small businesses to bring novel or improved imaging modalities of fully developed imaging technologies for cancer immunotherapies to the clinic and the market.

Phase I Activities and Deliverables

Phase I activities should generate scientific data confirming the clinical potential of the proposed imaging for cancer immunotherapies. The Phase I research plan must contain specific, quantifiable, and testable feasibility milestones.

Expected activities may include:

Demonstrate proof-of-concept for the development of a novel, modification of an existing imaging technology or approach to identify patients who are likely to respond to immunotherapies, and/or evaluate efficacy and toxicities of immunotherapy, and/or monitor tumor prognosis under immunotherapy using the imaging technology.

Quantify sensitivity and specificity of such imaging technology or approach.

Conduct preliminary biosafety study for the imaging technology or approach.

Benchmark experiments against current state-of-the-art methodologies.

Present Phase I results and future development plan to NCI staff.

Phase II Activities and Deliverables

Phase II should follow the development plan laid out in the Phase I and should further support commercialization of proposed imaging technology for cancer immunotherapies. The Phase II research plan must contain specific, quantifiable, and testable milestones.